Risky mistakes with Medical Device Compliant Handling -- Challenges in Understanding Compliant Procedures

Why Should You Attend:

Ineffective or lack of proper Complaint Handing is cited as one of the top violations in a 483 issued at time of inspection by FDA. Manufacturers of any class of medical devices are NEVER exempted from the Quality System regulation for complaint requirements (820.198). Medical Device firms and Designated Agents for foreign firms don’t understand the entire realm of the complaint process. This webinar will present FDAs current Medical Device Complaint Handling Procedures and how to review and process them for next steps in post-market evaluations. You will come away with a broad understanding of regulatory steps to track and trend complaint process, common mistakes and potential consequences of non-compliance during review. Learn what it takes to stay in compliance and the avoid risk of non-compliance and potential consequence of not understanding an issue with your product.

Poor strategies can lead to overlooked or lost information related to product reliability, raising concerns of public health and safety. Complaint Handling is no easy task; Customer satisfaction plays a significant role in measuring a product’s postmarket performance. It is an indicator of how effective the product performance is managed. Both the quality system regulation (QSR) and the International Organization for Standardization (ISO) require procedures and processes to monitor and control customer complaints. The complaint-handling mechanism not only collects feedback from unsatisfied customers, but also provides means for failure investigations and subsequent corrective and preventive actions (CAPA).

This webinar will provide:

• An understanding why inadequate procedures or not following procedures for receiving, reviewing, and evaluating complaints will cause both a financial and regulatory burden.
• The disconnect between complaints with adverse events and MDR requirements.
• Timely process of information received
• Why training personnel is so important
• The challenges of implementation of a proper management strategy for tracking and monitoring complaint-handling performance.

Areas Covered in the Webinar:

• Up to date information to help you understanding the meaning of a complaint
• Identify poor performance in the overall quality system
• Aid in implementing solutions to quality problems
• Regulations and Guidances for 820.198
• Verify confidence in and improve your complaint handling unit
• When a complaint turns into a medical device reporting (MDR)
• Avoid mistakes made by counterpart firms
• Improve customer relations by reducing the frequency of problems, complaints, and results
• Assure compliance with device regulations and consensus standards.

Who Will Benefit:

This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting.

• Regulatory Affairs
• QA/QC
• Project Managers
• Regulatory Professional
• Risk Managers
• Complaint Handling Teams
• CAPA Teams

From

• FDA Medical Device Firms

Rita Hoffman
Managing Partner, RHoffman Inc

Rita Hoffman is the Principal Consultant/Owner of Regs & Recall Strategies, LLC, and a consulting firm providing regulatory insight focusing on industry assistance on FDA compliance issues. Ms. Hoffman has been consulting with FDA firms on post marketing issues for the past 6 years.

Ms. Hoffman spent more than 37 years with the FDA prior to retiring in 2011 she was the recall branch chief for the Center for Devices and Radiological Health (CDRH). She was responsible for oversight and review of all medical devices recalls with extensive knowledge of the legal authority of 21 CFR Parts 7 & 806, 803 and 820 of the Act. During Ms. Hoffman’s tenure with FDA, she served in several critical headquarter positions including: compliance officer, ombudsman, jurisdictional review officer, small business liaison, and policy analyst.

Ms. Hoffman has a diversified knowledge encompassing FDA scientific, investigational and regulatory policy and compliance areas due to her in-depth understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. Throughout her FDA career, she has provided guidance and clarified FDA requirements, to industry, foreign governments, public entities and FDA field personnel involving recalls, labeling issues, dietary supplements, pharmaceuticals, OTC drug products and combination products.

Ms. Hoffman, in addition to RAPS Certified, is the recipient of RAPS Special Recognition Award for her unique contributions and achievements of individuals and organizations that advance the quality of health and regulatory affairs. She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, working in collaboration with both chapter members and FDA to increase professional awareness of regulatory issues. Ms. Hoffman holds a BS from the University of Maryland and has received many additional awards from both government and industry including the FDA Distinguished Government Service Award and Outstanding Service Awards for her Compliance work and industry contributions.

Follow us :